| CTRI Number |
CTRI/2026/01/101281 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of Ayurvedic chavyadimadhu yoga in Reducing Abdominal Fat And High Blood Cholesterol. |
|
Scientific Title of Study
|
Randomized controlled clinical study to evaluate the efficacy of chavyadimadhu yoga with vidangadi churna in the management of medoroga with special reference to visceral fat and hyperlipidemia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shweta Bharat Shinde |
| Designation |
PG Scholar |
| Affiliation |
Siddhakala Ayurveda college and research center sangamner |
| Address |
OPD NO 1 Kayachikitsa Department, Siddhakala Ayurved Mahavidyalaya , Pimparne Road, Sangamer Khurd, Sangamner,Dist.Ahilyanagar, Maharashtra 422605
OPD NO 1 Kayachikitsa Department, Siddhakala Ayurved Mahavidyalaya , Pimparne Road, Sangamer Khurd, Sangamner,Dist.Ahilyanagar, Maharashtra 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9021545794 |
| Fax |
|
| Email |
shwetashinde6070@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Gorakh Mane |
| Designation |
Professor |
| Affiliation |
Siddhakala Ayurveda College and Research Center Sangamner |
| Address |
OPD NO 1 Kayachikitsa Department, Siddhakala Ayurved Mahavidyalaya , Pimparne Road, Sangamer Khurd, Sangamner,Dist.Ahilyanagar, Maharashtra 422605
OPD NO 1 Kayachikitsa Department, Siddhakala Ayurved Mahavidyalaya , Pimparne Road, Sangamer Khurd, Sangamner,Dist.Ahilyanagar, Maharashtra 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9730657903 |
| Fax |
|
| Email |
drsgmane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shweta Bharat Shinde |
| Designation |
PG Scholar |
| Affiliation |
Siddhakala Ayurveda college and Research Center Sangamner |
| Address |
OPD NO 1 Kayachikitsa Department, Siddhakala Ayurved Mahavidyalaya , Pimparne Road, Sangamer Khurd, Sangamner,Dist.Ahilyanagar, Maharashtra 422605
OPD NO 1 Kayachikitsa Department, Siddhakala Ayurved Mahavidyalaya , Pimparne Road, Sangamer Khurd, Sangamner,Dist.Ahilyanagar, Maharashtra 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9021545794 |
| Fax |
|
| Email |
shwetashinde6070@gmail.com |
|
|
Source of Monetary or Material Support
|
| Siddhakala Ayurved Mhavidyalaya,Pimparne road,Sangamner khurd,Sangamner,Ahilynagar,Maharashtra,India.Pincode-422605 |
|
|
Primary Sponsor
|
| Name |
Shweta Bharat Shinde |
| Address |
Siddhakala Ayurved Mhavidyalaya,Pimparne road,Sangamner khurd,Sangamner,Ahilynagar,Maharashtra,India.Pincode-422605 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shweta Bharat Shinde |
Siddhakala Ayurveda Mahavidyalay And Hospital,Pimparne Road, Sangmaner |
Siddhakala Ayurveda Mahavidyalaya and Hospital,Pimparne Road, Department of Kayachikitsa OPD No 1 Sangamner khurd, Sangamner, Ahilyanagar, Maharashtra,India Pincode-422605
Ahmadnagar
MAHARASHTRA |
9021545794
shwetashinde6070@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Board Of Research And Statistics Committee Of Siddhakala Ayurved Mahavidyalaya , Sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vidangadi Churna, Reference: Bhaishajya Ratnavali, Medoroga Adhyay ,Page No-526, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: Medicine to be given Early Morning and Evening before meal | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chavyadimadhu Yoga, Reference: Gadnigraha Medoroga , Adhyay 15, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: Chavyadimadhu Yoga 3gm and Sattu 6gm with Madhu BD Early in Morning and Evening Before Meal Can Be Taken. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with BMI greater than 25 kilogram per meter square and less than 40 kilogram per meter square.
2.Patient present with any 3 classical signs and symptoms of Ashtodosha of Medorog.
3. Patients who give informed consent should involve.
|
|
| ExclusionCriteria |
| Details |
1. Patient with BMI greater than 40 kilogram per meter square.
2. Pregnant and lactating mother.
3. Patient having history of Renal disease, HIV, HbsAg.
4. Patient having acute complication like Coronary Heart Disease (CHD), Acute infective hepatitis and Alcoholic hepatitis.
5. Patient having known case of carcinoma of any type in the body
6. Patient having endocrine disorder like hypothyroidism and diabetes.
7. Patient on prolonged medication with corticosteroid, NSAIDs, Antidepressant
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To asses comparative Efficacy of Chavyadimadhu Yoga with Vidangadi Churn in the management of Medoroga with special reference to Visceral fat and Hyperlipidemia. |
0th Day (Baseline assessment) and 28th Day (Final assessment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-To assess Comparative Efficacy of Chavyadimadhu Yoga with Vidangadi Churn in management of Medoroga in reduction of Visceral fat and lipid level
-To Study Detail About Sign and Symptoms of Medorog as per Ayurveda and Modern Science
-To Study the Chavyadi Madhu Yoga in detail.
-To Study the Adverse Event if any occur. |
0 th (baseline ), 14 th , 28 th day ( Final assessment ) |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
09/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This Study is a Randomized Open Labelled Controlled Clinical Trial Comparing the Safety and Efficacy of Chavyadimadhu Yoga 3gm and Sattu 6gm with Madhu BD and Controlled Drug Vidangadi Churna 3gm with Madhu BD For 28 Days in 110 Patients of Medoroga Divided in Two Groups and the Effect on Total Serum Cholesterol , Serum Triglycerides , Serum LDL ,Serum HDL , Serum VLDL , Weight , BMI , Waist Circumferecne ,Hip circumferemce , Mid upper arm circumference , Skin flod thickness , Visceral fat will be assessed before and after treatment. |